At a glance
- Cortexin is not an FDA-approved drug: Drugs@FDA has no record of it.
- PubMed lists 199 publications mentioning it, including 17 randomized controlled trials and 46 animal-only studies.
- No study registered on ClinicalTrials.gov tests it as an intervention.
- FDA's adverse event system (FAERS) holds 9 reports mentioning it; 6 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- [Expert Council resolution: adjunctive pharmacotherapy for hyperkinetic disorders (attention deficit hyperactivity disorder) in children and adolescents].
- [Neurocognitive characteristics in children with sluggish cognitive tempo].
- [Cortexin in the comprehensive therapy of alcoholic encephalopathy].
- [Evaluation of the efficiency of combined neuroprotection and high-intensity magnetotherapy in the medical rehabilitation of patients with ischemic stroke].
- [Cortexin in the comprehensive treatment of neurological complications of type 2 diabetes mellitus. (Results of the DIACORT multicenter randomized clinical trial)].
- Sex Differences in Affective Disorders: A Developmental Neuroscience Framework on the Role of Puberty.
- [The effect of neuroprotectors on the level of BDNF, tumor necrosis factor alpha and apoptosis markers, and in acute cerebrovascular accidents].
- [Efficacy and safety of Cortexin as additional therapy in patients with depressive disorder].
- Distinct amygdalar pathways to frontopolar cortex and medial temporal lobe support temporal memory for emotional events.
- [Problematic internet use by children with attention deficit hyperactivity disorder].
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
No registered study on ClinicalTrials.gov lists this peptide as an intervention.
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 9
- Serious
- 6
- With death outcome
- 1
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.